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US FDA Admits Risks of Mercury Dental Fillings, Settles Lawsuit
Date:6/5/2008

Statement of Michael Bender, Plaintiff

WASHINGTON, June 5 /PRNewswire-USNewswire/ -- "After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women and unborn babies, and children. This about-face resulted from settling, earlier this week, our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al. The FDA must now finish classification within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009. The FDA also agreed to and, with uncharacteristic speed, has already changed its website on mercury amalgam -- dramatically.

Gone are all of FDA's claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 FDA advisory panel affirmed amalgam's safety, all of which are untrue. Instead, the FDA has moved to a more neutral course, while still recognizing the serious health risks posed by amalgam in particular for children and unborn children, for pregnant women, and for those with mercury immuno-sensitivity.

The Updated June 3, 2008 FDA website (see: http://www.fda.gov/cdrh/consumer/amalgams.html) now states, for example:

"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus."

"Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner."

In September 2006, an advisory panel to the FDA reviewed FDA's research and heard presentations from the public about the benefits and risks of mercury and amalgam. The joint committee concluded with personal recommendations by the members. These include that FDA should:

Consider informed consent for patients receiving amalgam

Consider labeling changes restricting its use in pregnant woman and children

Consider the relevancy of the "precautionary principle"

You can read the summary of the FDA advisory panel meeting at: http://www.fda.gov/cdrh/meetings/090606-summary.html

The FDA website now also states that "Some other countries follow a 'precautionary principle' and avoid the use of dental amalgam in pregnant women. The FDA provides links to advice about dental amalgams from regulatory agencies in other countries:

Canada: http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/1996/1996_63_e.html

France: http://afssaps.sante.fr/ang/pdf/amalgam.pdf

Sweden: http://www.kemi.se/templates/Page.aspx?id=5233 "

The plaintiffs included a team of four nonprofit groups, two public officials, three dental professionals, and two consumer victims: Moms Against Mercury (Amy Carson and Angela Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark Mitchell), Oregonians for Life (Mary Starrett), mercury expert Michael Bender (as a of the Vermont Advisory Committee on Mercury Pollution), Arizona Senator Karen Johnson, Dr. Andy Landerman, Dr. Corrie Crowe, dental assistant Karen Palmer, consumer advocates Linda Brocato and Anita Vazquez Tibau, and Consumers for Dental Choice.

For More Information: http://www.mercurypolicy.org


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SOURCE Mercury Policy Project
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